Echinacea Versus Placebo Effect in Common Cold (Physician Echinacea Placebo) (PEP)

University of Wisconsin (UW)

Status and phase: Completed; Phase 3

Conditions: Common Cold

Treatments: Dietary Supplement: Echinacea; Other: Blinded placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00065715

BarrettB

R01AT001428 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;

1. The effect of receiving blinded placebo, compared to no treatment; and
2. The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.

Full description

As per Brief Summary

Enrollment: 719 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suspected or known cold
• At least one of the following cold symptoms:

nasal discharge, nasal congestion, sneezing, or sore throat

• Enrolled in school, for children 12 to 17 years of age

Exclusion criteria

• Pregnancy;
• Symptom duration > 36 hrs
• Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
• Anticipated need for symptom-relieving meds during cold
• Autoimmune/deficiency disease
• History of allergic rhinitis with current eye itching/sneezing
• History of asthma w/current cough/SOB
• Prior study entry
• Allergy to Echinacea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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719 participants in 4 patient groups, including a placebo group

A

No Intervention group

Description:

No pills

B

Placebo Comparator group

Description:

Blinded placebo

Treatment:

Other: Blinded placebo

C

Experimental group

Description:

Echinacea - Blinded

Treatment:

Dietary Supplement: Echinacea

D

Experimental group

Description:

Echinacea - Unblinded, Open Label

Treatment:

Dietary Supplement: Echinacea